U.S. patent application number 12/998587 was filed with the patent office on 2011-11-10 for inhaler device.
This patent application is currently assigned to MEDISPRAY LABORATORIES PVT. LTD. Invention is credited to Rajesh Sawant.
Application Number | 20110271958 12/998587 |
Document ID | / |
Family ID | 41463021 |
Filed Date | 2011-11-10 |
United States Patent
Application |
20110271958 |
Kind Code |
A1 |
Sawant; Rajesh |
November 10, 2011 |
INHALER DEVICE
Abstract
The present invention provides an inhaler device (1) for
dispensing doses of medicament, the inhaler comprising means for
receiving a compartment (42) containing medicament; and medicament
extraction facilitating means (22) for locating in a received
compartment (42) and thereby allowing an extraction of medicament
from said compartment (42); wherein the extraction facilitating
means (22) comprises (i) a first fluid pathway extending
therethrough for directing extracted medicament to an outlet of the
inhaler (1) and (ii) means which, in use, provides a second fluid
pathway for directing fluid into said compartment (42) past a
sealing material of the compartment (42) pierced by said extraction
facilitating means (22).
Inventors: |
Sawant; Rajesh; (Navi
Mumbia, IN) |
Assignee: |
MEDISPRAY LABORATORIES PVT.
LTD
|
Family ID: |
41463021 |
Appl. No.: |
12/998587 |
Filed: |
November 9, 2009 |
PCT Filed: |
November 9, 2009 |
PCT NO: |
PCT/GB2009/002635 |
371 Date: |
July 25, 2011 |
Current U.S.
Class: |
128/203.21 ;
128/203.12 |
Current CPC
Class: |
A61M 15/0075 20140204;
A61M 15/0036 20140204; A61M 15/0045 20130101; A61M 2202/064
20130101; A61M 11/003 20140204; A61M 15/0041 20140204; A61M 15/0048
20140204 |
Class at
Publication: |
128/203.21 ;
128/203.12 |
International
Class: |
A61M 15/00 20060101
A61M015/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 6, 2008 |
IN |
2663/MUM/2008 |
Claims
1. An inhaler device for dispensing doses of medicament, the
inhaler comprising means for receiving a compartment containing
medicament; and medicament extraction facilitating means for
locating in a received compartment and thereby allowing an
extraction of medicament from said compartment; wherein the
extraction facilitating means comprises (i) a first fluid pathway
extending therethrough for directing extracted medicament to an
outlet of the inhaler and (ii) means which, in use, provides a
second fluid pathway for directing fluid into said compartment past
a sealing material of the compartment pierced by said extraction
facilitating means.
2. The inhaler device according to claim 1, wherein the extraction
facilitating means comprises an element for piercing a sealing
material of a received compartment, said element comprising a first
part provided with said first fluid pathway therein and a second
part providing said second fluid pathway.
3. The inhaler device according to claim 2, wherein the second part
is an element extending laterally of the first part which, in use,
spaces pierced sealing material from the first part.
4. The inhaler device according to claim 3, wherein the second part
extends laterally from the first part and is connected thereto.
5. The inhaler device according to claim 3 4, wherein the second
part is a planar member.
6. The inhaler device according to claim 2, wherein the second part
provides said second fluid pathway as a pathway extending through
said part.
7. The inhaler device according to claim 6, wherein the second part
comprises an inlet aperture at an end thereof distal to an opposite
end thereof which, in use, locates in a received compartment.
8. The inhaler device according to claim 7, wherein, in an
extraction position of the medicament extraction facilitating
means, the inlet aperture of the second part locates on one side of
pierced sealing material external to the compartment and said
opposite end of the second part locates on the other side of the
pierced sealing material internal to the compartment.
9. The inhaler device according to claim 7, wherein the second part
comprises an outlet aperture at said opposite end thereof.
10. The inhaler device according to claim 2, wherein the second
part comprises at least one piercing member cantilevered to the
first part.
11. The inhaler device according to claim 10, wherein the piercing
element comprises a ridge for piercing a sealing material of a
compartment, and wherein said piercing ridge extends from the first
part to the second part.
12. The inhaler device according to claim 11, wherein the piercing
ridge is an apex formed by the meeting of two surfaces.
13. The inhaler device for dispensing multiple doses of medicament
according to claim 1, the inhaler comprising means for receiving a
medicament cartridge comprising a plurality of compartments
containing medicament; and operating means moveable in first and
second directions by a user; wherein the medicament extraction
facilitating means is movable from a retracted position to an
extraction position in response to movement of the operating means
in the first direction, the extraction position of the medicament
extraction facilitating means allowing extraction of medicament
from said cartridge compartment upon inhalation by a user, and the
retracted position allowing advancement of the medicament
cartridge, and wherein the medicament cartridge is driven by the
operating means so as to advance a cartridge compartment into a
predetermined position relative to the medicament extraction
facilitating means in response to movement of the operating means
in the second direction.
Description
[0001] The present invention relates to inhalers for the
administering of medicament. The invention relates particularly to
inhalers which are used with piercible sealed compartments of
medicament and, more particularly, to inhalers for receiving
cartridges having a plurality of such compartments. Such inhalers
allow for the administration of predetermined doses of medicament
(typically a dry powder medicament).
[0002] A wide variety of inhalers are presently available on the
market, which are designed to receive one or more sealed
compartments of medicament. When medicament in a particular
compartment is required for inhalation by a user of the inhaler
device, a piercing member is used to pierce a seal of the
compartment and extend through said seal into proximity with the
medicament contained within the compartment. The medicament may
then be inhaled through a flow path extending through the piercing
member into the compartment.
[0003] A problem associated with inhalers of the above type is that
a rapid inhalation of air (and medicament) through said flow path
in the piercing member tends to be difficult for a user.
[0004] It is an object of the present invention to provide an
inhaler device which allows air and medicament to be inhaled more
readily and rapidly.
[0005] A first aspect of the present invention provides an inhaler
device for dispensing doses of medicament, the inhaler comprising
means for receiving a compartment containing medicament; and
medicament extraction facilitating means for locating in a received
compartment and thereby allowing an extraction of medicament from
said compartment; wherein the extraction facilitating means
comprises (i) a first fluid pathway extending therethrough for
directing extracted medicament to an outlet of the inhaler and (ii)
means which, in use, provides a second fluid pathway for directing
fluid into said compartment past a sealing material of the
compartment pierced by said extraction facilitating means.
[0006] The extraction facilitating means ideally comprises an
element for piercing a sealing material of a received compartment,
said element comprising a first part provided with said first fluid
pathway therein and a second part providing said second fluid
pathway. The second part may be an element extending laterally of
the first part which, in use, spaces pierced sealing material from
the first part.
[0007] Preferably, the second part extends laterally from the first
part and is connected thereto. The second part may be a planar
member.
[0008] Alternatively, the second part ideally provides said second
fluid pathway as a pathway extending through said part. The second
part may comprise an inlet aperture at an end thereof distal to an
opposite end thereof which, in use, locates in a received
compartment.
[0009] In an extraction position of the medicament extraction
facilitating means, the inlet aperture of the second part
preferably locates on one side of pierced sealing material external
to the compartment and said opposite end of the second part ideally
locates on the other side of the pierced sealing material
internally within the compartment.
[0010] Ideally, the second part comprises an outlet aperture at
said opposite end thereof.
[0011] It is also preferable for the medicament extraction
facilitating means to comprise a ridge for piercing a sealing
material of a compartment, and wherein said piercing ridge extends
from the first part to the second part. The piercing ridge may be
an apex formed by the meeting of two surfaces.
[0012] The inhaler device may be for dispensing multiple doses of
medicament, the inhaler comprising means for receiving a medicament
cartridge comprising a plurality of compartments containing
medicament; and operating means moveable in first and second
directions by a user; wherein the medicament extraction
facilitating means is movable from a retracted position to an
extraction position in response to movement of the operating means
in the first direction, the extraction position of the medicament
extraction facilitating means allowing extraction of medicament
from said cartridge compartment upon inhalation by a user, and the
retracted position allowing advancement of the medicament
cartridge, and wherein the medicament cartridge is driven by the
operating means so as to advance a cartridge compartment into a
predetermined position relative to the medicament extraction
facilitating means in response to movement of the operating means
in the second direction.
[0013] The inhaler device may comprise medicament extraction
facilitating means comprising a resiliently displaceable
member.
[0014] The inhaler device may comprise medicament extraction
facilitating means wherein said means is sprung biased or is
operated by a cam mechanism and displaced over a pivot. Ideally,
said means is biased into a medicament extraction position allowing
extraction of medicament from a medicament cartridge. Preferably
said means is sprung biased by virtue of the resiliently
deflectable character of the material from which said means is
manufactured.
[0015] Preferably, the medicament extraction facilitating means
moves from the extraction position to the retracted position in
response to movement of the operating means in the second
direction.
[0016] The medicament extraction facilitating means may preferably
be formed from acetal, but ABS, nylon, polycarbonate, HDPE or LDPE
may also be used.
[0017] It will be understood therefore that an inhaler device
according to the present invention allows for a comparatively
simple operation by a user through appropriate movement of the
operating means. If a user wishes to inhale a dose of medicament
from a cartridge within the inhaler device, then the user need only
move the operating means in a first direction so as to move the
extraction facilitating means to an extraction position in which
medicament may be extracted from the cartridge compartment. A user
may then readily move the operating means in a second direction so
as to advance or index the next dose of medicament to an
appropriate position. Typically, this position will be one adjacent
to the piercing end of the medicament extraction facilitating
means. The medicament extraction facilitating means may be moved to
a retracted position which allows for the advancement of the
medicament cartridge. It will be appreciated that the operating
means may drive both the advancement of the cartridge and movement
of the medicament extraction facilitating means.
[0018] Whilst the operating means drives the medicament extraction
facilitating means to one of the extraction and retracted
positions, biasing means may be provided for moving the medicament
extraction facilitating means to the other of the extraction and
retracted positions. The biasing means may comprise a resilient
elastic member. The resilient elastic member may be provided as a
cantilever arm, with one end thereof fixed to a housing of the
inhaler device and a free end thereof being provided with the
medicament extraction facilitating means.
[0019] The operating means may, alternatively, drive the medicament
extraction facilitating means to both the extraction and retracted
positions. Biasing means may also be provided to bias the
medicament extraction facilitating means towards one of the
extraction and retracted positions.
[0020] The operating means may drive the medicament extraction
facilitating means through use of a cam arrangement. Ideally, a cam
is provided on the operating means. The cam may be provided as a
ramp surface. The arrangement may be such that, when the operating
member is moved in the second direction, the ramp surface moves
laterally in abutment with the medicament extraction facilitating
means and thereby displaces the medicament extraction facilitating
means. The medicament extraction facilitating means may be provided
with a roller or bearing before abutment with the cam.
[0021] The medicament extraction facilitating means may be provided
with a tubular element for locating in a cartridge compartment when
the medicament extraction facilitating means is located in the
extraction position. The cross-section of the tubular element may
have a circular, oval, square or rectangular shape. A free end of
the tubular element may be provided with a piercing portion. The
piercing portion may be of a frusto-conical shape. Alternatively,
the piercing portion may have the shape of a triangular based
pyramid or prism. Furthermore, the arrangement of the medicament
extraction facilitating means may be such that, when the medicament
extraction facilitating means is located in the extraction
position, the tubular element is in fluid communication with a
mouthpiece of the inhaler device. This fluid communication may be
made through an aperture or discontinuity in the operating means.
This aperture or discontinuity is ideally aligned with a flow path
through the mouthpiece when the operating means has been moved in
the first direction so as to drive the medicament extraction
facilitating means into the extraction position.
[0022] The mouthpiece may also include an opening (through which
medicament is inhaled) which is provided with a filter for
deaggregation of the medicament/fluid to be inhaled and/or helical
guide vanes for imparting a swirl motion onto medicament/fluid to
be inhaled. Other means for imparting a swirl motion on
medicament/fluid may be provided.
[0023] It is also preferable for the operating means to close a
flow path through the mouthpiece when the operating means is moved
in the second direction. Ideally, the aperture or discontinuity is
moved out of alignment with the mouthpiece flow path when the
operating means is moved in the second direction. Fluid
communication between the mouthpiece and the extraction
facilitating means is ideally prevented when the medicament
extraction facilitating means is in the retracted position.
[0024] Furthermore, the medicament extraction facilitating means
may optionally comprise a venturi.
[0025] It is also desirable for ratchet means to be provided for
allowing the operating means to drive the medicament cartridge. The
operating means may be provided with a ratchet tooth so that the
medicament cartridge is moved in response to movement of the
operating means in the second direction, but is not moved in
response to movement of the operating means in the first direction.
Said ratchet tooth may be arranged so as to engage in turn with
each of a plurality of ratchet teeth provided on the medicament
cartridge.
[0026] Ideally, said first direction is opposite to said second
direction. It is also preferable for movement of the operating
means in said first and second directions to comprise a movement of
the operating means along a part-circular path. The part-circular
path is ideally concentrically positioned relative to an annular
arrangement of medicament compartments of the medicament
cartridge.
[0027] An element of the operating means may extend through a slot
in a housing of the inhaler device. The slot is ideally configured
so as to allow movement of said element between opposite ends of
the slot and thereby move the operating means in said first and
second directions. Retaining means may be provided for preventing
movement of said element of the operating means. Said retaining
means may be provided on a cover for the mouthpiece, possibly as
part of a cover for the mouthpiece.
[0028] The inhaler device may be provided with means for retaining
a medicament cartridge in a required position. The retaining means
may comprise a roller, wheel, bearing or cam to press against the
cartridge whilst allowing movement of the cartridge. The retaining
means may be sprung biased so as to press against the medicament
cartridge and/or between teeth of the cartridge. The retaining
means may be made from acetal, but may be made from ABS, nylon,
polycarbonate, HDPE or LDPE. The inhaler may also comprise means
for driving a dose counter in response to movement of a medicament
cartridge. Said drive means may comprise one or more teeth or
detents for engaging a medicament cartridge. The drive means may
also comprise a gear wheel for engaging means for displaying a dose
count.
[0029] Embodiments of the present invention will now be described
with reference to the accompanying drawings, in which:
[0030] FIG. 1 is a perspective view of the exterior of an inhaler
device according to the present invention;
[0031] FIG. 2 is a top view of the exterior of the inhaler device
shown in FIG. 1;
[0032] FIG. 3 is a bottom view of the exterior of the inhaler
device shown in FIG. 1;
[0033] FIG. 4 is a side view of the exterior of the inhaler device
shown in FIG. 1;
[0034] FIG. 5 is a perspective view of the exterior of the inhaler
device of FIG. 1 shown in an operative position wherein a spiking
component within the inhaler is piercing a sealed compartment of
medicament;
[0035] FIG. 6 is a perspective view of a base of the inhaler device
of FIG. 1, with a medicament cartridge and internal components of
the inhaler device mounted on said base;
[0036] FIG. 7 is a perspective view of a body (or middle
compartment) of the inhaler device with internal components of the
inhaler device mounted on said middle cover;
[0037] FIG. 8 is an enlarged view of the spike component mounted on
said middle cover;
[0038] FIG. 9 is a perspective view of a base of a modified inhaler
device, with a medicament cartridge and internal components of the
modified inhaler device mounted on said base;
[0039] FIG. 9A is a perspective view of a modified deformable
member shown in FIG. 9;
[0040] FIGS. 10A-G are perspective, front, right side, rear, left
side, top and bottom views respectively of an operating member of
the inhaler device;
[0041] FIG. 11 is a perspective view of a first type of spiking
component;
[0042] FIG. 12 is a perspective view of a second type of spiking
component; and
[0043] FIG. 13 is a side view of a third type of spiking
component.
[0044] An inhaler device 1 is shown in the accompanying drawings
which comprises an outer housing and a plurality of internal
components including a cartridge having a plurality of compartments
containing medicament. Amongst the internal components are an arm
90 mounted to the housing, a spiking component 22 mounted to the
arm 90, a dose counter mechanism, and an operating member 54.
[0045] The housing comprises a base 2, a middle cover 4, and a top
cover 6 (see FIGS. 1 to 5). Four apertures 100 are provided along
an upper perimeter edge 102 of the base 2 (see FIG. 6) in order to
receive four posts 104 extending downwardly from a lower perimeter
edge 106 of the middle cover 4 (see FIG. 7). The apertures 100 are
asymmetrically positioned along the perimeter edge 102 of the base
2 and the posts 104 are arranged in corresponding positions along
the perimeter edge 106 of the middle cover 4 so that all four posts
104 can only be simultaneously inserted within the apertures 100
when the base 2 and middle cover 4 are correctly aligned in a
particularly required position relative to one another. With the
base 2 and middle cover 4 correctly aligned, two further posts 11
upstanding from the interior surface of the base 2 snap fit into
two cylindrical bosses 13 upstanding from the interior surface of
the interior surface of the middle cover 4. The base 2 and middle
cover 4 are thereby secured to one another. The top cover 6 is
attached to the middle cover 4 using an arrangement of posts and
which are retained in corresponding apertures. Other means of
attachment may be used.
[0046] The housing is provided with a mouthpiece 8 and a mouthpiece
cover 10. An aperture 14 in the front side of the housing allows
for fluid communication through the mouthpiece 8 between the
interior and exterior of the inhaler housing. The aperture 14 is
optionally provided with a mesh 114 for deaggregation of the
medicament particles prior to inhalation. In use, a user of the
inhaler device 1 places the mouthpiece to the lips of their mouth
and inhales through the mouthpiece so as to extract and inhale
medicament.
[0047] In an alternative embodiment, the mouthpiece 8 may be
replaced with a construction suitable for nasal inhalation.
[0048] One or more further apertures may be provided in the rear of
the housing, which assists with allowing a flow of air into the
housing during inhalation of medicament by a user.
[0049] The housing is also provided with a slot 18 along which a
knob 20 may be moved so as to advance a cartridge of medicament
within the housing and so as to displace a spiking component 22.
The mouthpiece cover 10 is pivotally arranged relative to the knob
by means of a hinge arrangement 12. The cover 10 and knob 20 may be
an integral unitary component with the hinge arrangement comprising
a resilient flexible element, or the cover 10 and knob 20 may be
separate components with the hinge arrangement allowing said
separate components to be connected to one another in such a way as
to allow a relative rotation between them. In this latter case, the
hinge arrangement may provide for the two components to be
snap-fitted to one another, for example, by the location of two
opposing bosses on one of said components into two opposing
apertures or recesses in the other of said components.
[0050] The coupling of the cover 10 and the knob 20 allow them to
be conveniently moved together during actuation of the device. In
particular, a single hand can be used to open the mouthpiece cover
10 and actuate the device by moving the knob 20.
[0051] An aperture or window 24 is also provided in the middle
cover 4 and the top cover 6 so that an indication of the number of
doses used or the number of doses remaining can be seen provided on
a dose counter wheel 26 located within the housing.
[0052] The counter wheel 26 is located on and rotatably attached to
a first boss 28 upstanding from an interior surface of the middle
cover 4. A drive wheel 30 for rotating the counter wheel 26 is
located adjacent said interior surface of the middle cover 4 and is
rotatably mounted to a second boss 32. The second boss (provided as
a cylindrical member) upstands from an interior surface of the base
2 and, in the assembled inhaler device, extends to a position
proximate said interior surface of the middle cover and is
positioned relative to the first boss 28 so that the drive wheel 30
drivingly engages with the counter wheel 26. This engagement may
be, for example, by means of gear teath (not shown) or by friction
alone.
[0053] A drive gear 33 is also rotatably mounted on the second boss
32 and is located adjacent said interior surface of the base 2 from
which the second boss 32 upstands. The drive wheel 30 and drive
gear 33 are connected to one another by means of an axle connected
to the centre of said drive wheel 30 and gear 33. The axle is
provided as a two-part cylindrical shaft, which receives the second
boss 32 within its interior and extends along the length of the
second boss 32. A first part 35 of the axle is connected to the
drive wheel 30 and a second part 37 of the axle is connected to the
drive gear 33. The two parts 35,37 are connected to one another by
means of mating castellations 41,43 provided on the ends of the two
parts 35,37 distal to the the drive wheel 30 and drive gear 33
respectively. Alternative means for connecting the two parts 35,37
may be used.
[0054] In use, the drive gear 33 is rotated by the rotation of a
medicament cartridge 38 and, due to the engagement of the
castellations 41,43 on the two parts of the axle, the drive gear 33
rotates the drive wheel 30 which, in turn, rotates the counter
wheel 26. In this way, an appropriate indicator provided on the
upperside of the counter wheel 26 may be viewed through the window
24 and thereby provide a user with an indication of the remaining
doses or the doses used.
[0055] Three equi-spaced support members 40 are provided on the
interior surface of the base 2 to ensure a medicament cartridge 38
locates and rotates correctly adjacent said surface. The support
members 40 are part-circular and positioned on the circumference of
the same circle. The medicament cartridge 38 locates below the
counter wheel 26 and drive wheel 30 but in the same plane as the
drive gear 33.
[0056] The cartridge 38 is provided as an annular ring having a
plurality of compartments 42. Specifically, the cartridge 38 has
sixty to seventy compartments. Each compartment contains medicament
in a powder form. The annular ring comprises two operative walls--a
radially outer operative wall and a radially inner operative wall.
Both walls are provided with a plurality of teeth. The inner wall
comprises a plurality of integral teeth 44, which engage with a
plurality of teeth 46 provided on the perimeter of the drive gear
33. The arrangement is such that a small number of teeth 46 are
engaged at any one time with the same number of teeth 44 of the
medicament cartridge 38. Thus, as the cartridge 38 rotates (with
the inner cartridge wall abutted and guided by the three support
members 40), the drive gear 33 is rotated on the boss 32 by virtue
of the engagement between the aforesaid teeth 44, 46.
[0057] Rotary movement of the medicament cartridge 38 is resisted
by means of a resiliently deformable member 52, which is sprung
biased so as to be press into abutment with the radially inner wall
of the cartridge 38 between the teeth 44 thereof. The deformable
member 52 comprises an element for locating between said teeth 44.
The element has a V-shape. The deformable member 52 further
comprises two legs, each leg extending from a side of said element
and having an aperture therein which is fitted onto one of two
posts 53 upstanding from the base 2. The posts 53 have a flange
(not shown) provided on their free ends so as to retain the
deformable member 52 on the base 2.
[0058] The cartridge 38 will only rotate if sufficient force is
applied to the cartridge 38 to overcome the bias of said deformable
member 52 and thereby slide the deformable member 52 over the teeth
44. In this way, undesirable rotation of the medicament cartridge
38 is prevented and the cartridge itself is always biased towards
one of a plurality of predetermined rotary positions.
[0059] The medicament cartridge 38 is moved from one medicament
compartment 42 to the next, during use, by moving an operating
member 54. An element 56 of the operating member 54 extends through
the slot 18 and attaches with the knob 20. The element 56 is
provided with a clip 120 for attaching the element 56 to the knob
20. The operating member 54 comprises a ratchet tooth 58, which
engages with a plurality of ratchet teeth 60 provided on the outer
operative wall of the medicament cartridge 38. The configuration
and engagement of the ratchet teeth 58, 60 is such that, when the
operating member 54 is moved in the direction of arrow A (see FIG.
6) the ratchet tooth 58 of the operating member 54 abuts against an
adjacent ratchet tooth 60 of the cartridge 38 and rotates the
cartridge 38 in the direction of arrow A. The extent of movement of
the operating member 54 allowed by the slot 18 indexes the
cartridge 38 by one compartment 42 (i.e. to the next compartment
42). The movement of the cartridge 38 will also be understood to
drive the dose counter wheel 26 as already described above.
[0060] When the operating member 54 is moved in an opposite
direction to that indicated by arrow A, the configuration of the
ratchet mechanism allows the ratchet tooth 58 on the operating
member 54 to ride over the ratchet teeth 60 of the cartridge 38
without exerting sufficient force to overcome the bias of the
deformable member 52. The cartridge 38 is therefore not rotated by
movement of the operating member 54 in a direction opposite to that
indicated by arrow A.
[0061] The operating member 54 further comprises a sealing face
plate 66 which aligns with the flow path 14 associated with the
mouthpiece 8 when the operating member 54 has been moved to the
fullest extent in the direction indicated by arrow A. Furthermore,
the operating member 54 is provided with an aperture 68 which
aligns with the flow path 14 when the operating member 54 has been
moved to the fullest extend in the direction opposite to that
indicated by arrow A.
[0062] The operating member 54 yet further comprises a camming
member/strip or ramp 70, which engages with an end portion 72 of a
spiking component 22. The end portion may be provided with a roller
to assist with the camming action of the camming member. In the
assembled inhaler 1, the camming strip 70 is located above said end
portion 72 and the arrangement is such that, when the operating
member 54 is moved in a direction opposite to that indicated by
arrow A, the end portion 72 slides against the underside of the cam
strip 70 and is pressed downwardly by the camming strip 70 so as to
locate the spiking component within a previously advanced
compartment 42 of medicament. In so locating the spiking component
22, a seal provided across the top of the compartment 42 is
pierced/perforated by the spiking component 22.
[0063] The spiking component 22 comprises a perforating element 80,
the interior of which provides fluid communication between a
compartment (in which said component 22 locates) and the aperture
68 and flow path 14. Thus, with the operating member 54 having been
moved in a direction opposite to that indicated by arrow A, the
perforating element 80 is located in a compartment containing
medicament and the aperture 68 of the operating member 54 is
aligned with the mouthpiece flow path 14. Medicament may then be
inhaled from the medicament compartment from the mouthpiece.
[0064] The operating member 54 is also provided with a second
camming strip 130 located below the aperture 68. This second cam
130 is orientated so as to press the end portion 72 of the spiking
component 22 upwardly, thereby returning the support arm 90 to an
upper position within the housing (as the operating member 54 is
moved in a direction as indicated by arrow A). In this way, the arm
90 is returned to its storage/retracted position by means of a
camming action.
[0065] When the operating member 54 is moved back in the direction
indicated by arrow A, the aperture 68 is moved out of alignment
with the mouthpiece flow path 14. The flow path 14 is then covered
by the sealing plate 66 of the operating member 54. Also, as the
operating member 54 is moved in the direction of arrow A, the
downward pressure applied by the cam 70 is released to allow the
spiking component 22 to be moved upwardly by the second cam
130.
[0066] The arm 90 is secured to the middle cover 4 at an opposite
end of the arm 90 to the end portion 72. The arm 90 is pivotally
connected as a cantilever to the middle cover 4. This pivotal
connection allows the arm 90 to move to and from the
retracted/storage position without a bending or other deformation
of the arm 90. The arm 90 is therefore resiliently
displaceable.
[0067] The pivotal connection of the arm is provided by resilient
clip elements 132 projecting downwardly from the underside of the
middle cover 4. These clip elements 132 are provided with bosses
134 (only one of which is partially visible in FIG. 7) for
snap-fitting into apertures 136 (again, only one of which is
partially visible in FIG. 7) of the arm 90. The arm 90 is rotatable
up and down about the bosses 134. When the arm 90 is located in its
upper-most position within the housing of the inhaler device 1, the
arm 90 locates between two elements 138 projecting downwardly from
the underside of the middle cover 4. In this way, the end of the
arm 90 distal to the apertures 136 is prevented from moving from
side to side.
[0068] The arm 90 is not biased to a particular position, however
such a bias may be provided, if considered desirable, through use
of a spring.
[0069] It will be understood that sliding the operating member 54
in the direction of arrow A results in moving the inhaler 1 into a
closed position, whilst sliding the operating member 54 in the
direction opposite to that indicated by arrow A results in moving
the inhaler 1 into an open position.
[0070] The operating member 54 is located within the inhaler
housing in a groove 98. The groove 98 allows the operating member
54 to be displaced along the inner side of the housing (i.e.
circumferential movement) whilst limiting undesirable radial
movement.
[0071] An enlarged view of the spiking component 22 is shown in
FIG. 11 of the accompanying drawings. The spiking component 22
comprises a cylindrical member 102 defining a fluid pathway
therein. A spiking element 80 extends perpendicularly from the
exterior of the cylindrical member 102. A first part 103 of the
spiking element 80 has a rectangularly shaped cross-section. The
free end of the spiking element 80 is provided with two sloping
surfaces 104,106 which extend from the major sides (as opposed to
minor sides) of the rectangular first part 103 cross-section and
meet one another at an apex forming a ridge 108. The ridge 108 is
therefore parallel with the major sides (as opposed to minor sides)
of the rectangular first part 103 cross-section. In use, the ridge
108 pierces/perforates the seal of a medicament compartment.
[0072] The first part 103 of the spiking element 80 is provided
with a flow pathway (of rectangular cross-section) extending
therethrough. This flow pathway opens onto the sloping surfaces
104,106 to form an aperture 109 therein and is in fluid
communication with the fluid pathway extending through the
cylindrical member 102. In use, medicament is extracted from a
pierced compartment by inhalation breath through the aperture 109
in the direction indicated by arrow B.
[0073] The ridge 108 and, therefore, the sloping surfaces 104,106
extend beyond the first part 103 in a cantilever fashion. The
extended sloping surfaces 104,106 are supported by means of a
second part 110 in the form of a wall extending perpendicularly
from the exterior of the cylindrical member 102 to beneath the
ridge 108. The wall is oriented parallel with the major of the
rectangular first part 103 cross-section and the ridge 108. The
thickness of the wall is less than the width of the first part 103
(i.e. less than the length of the minor of the rectangular first
part 103 cross-section). As a consequence, a space is provided
either side of the second part 110 between the extended sloping
surfaces 104,106 and the cylindrical member 102. During use, when
the spiking element 80 is located in a pierced compartment, the
spiking element 80 (and, in particular, the first and second parts
103,110) push to one side material of the compartment which had
previously sealed said compartment. The space either side of the
second part 110 then allows inhalation breath to flow readily into
the pierced compartment (rather than being restricted from doing so
by sealing material). This flow of inhalation breath is indicated
by arrow C in FIG. 11 and the position of the compartment relative
to the spiking component is shown by dotted line 113. It will be
seen that the inhalation breath flows into said space, over the
edges of the extended sloping surfaces 104,106 and then over the
medicament (which is now located between the sloping surfaces
104,106 and the bottom of the compartment). Medicament thereby
becomes entrained into the air inhalation flow and passes from the
compartment via the aperture 109 in the sloping surfaces 104,106 as
indicated by arrow B. Also, the proximity of the sloping surfaces
104,106 to the bottom of the compartment reduces the likelihood of
the air flow to re-circulate repeatedly within the compartment
rather than immediately flowing out of the compartment. As a
result, a user may breath more readily through the inhaler device
and receive a full dose of medicament more rapidly and efficiently.
This is also assisted, in part, by the free end of the spiking
element 80 having a similar plan shape (rectangular) and size to
that of the medicament compartments.
[0074] It will be understood that alternative means may be provided
for allowing air to flow more readily into a pierced compartment
and/or for reducing the effective volume within a compartment to
thereby reduce a tendency for recirculation. For example, a second
spiking component 22' is shown in FIG. 12. The second spiking
component 22' is very similar to the first spiking component 22,
and like elements are identified in the drawings with like
reference numerals. However, the second spiking component 22' is
different from first spiking component 22 in that the wall of the
second part 110 is replaced with a rectangular box section 112
extending perpendicularly from the exterior of the cylindrical
member 102 to the extended sloping surfaces 104,106. This
rectangular box section 112 defines a second flow pathway (of
rectangular cross-section) extending through the spiking element 80
and opening onto the extended sloping surfaces 104,106 by means of
an outlet aperture 114 in said extended surfaces. An inlet aperture
116 is provided in the box section 112 adjacent the cylindrical
member 102 so as to allow inhalation breath to flow into a pierced
compartment via said second flow pathway and the outlet aperture
114, as indicated by arrow D in FIG. 12. The arrangement of the
inhaler is such that, when the spiking element 80 is located in a
pierced compartment, the pierced sealing material locates between
the free end of the spiking element 80 (i.e. the free end of the
box section 114) and the inlet aperture 116. In this way, air
flowing into the pierced compartment bypasses the pierced sealing
material by flowing into the inlet aperture 116, along the pathway
of the box section 112, and out of the outlet aperture 114. The
sealing material does not therefore then present an obstruction to
the flow of air into the compartment.
[0075] It should be noted that the cylindrical member 102 does not
open into the box section 112. The box section 112 is in fluid
communication with the interior of the cylindrical member 102 only
by means of the first part 103.
[0076] The fluid pathway in the cylindrical member 102 may extend
from a first end 120 of said member 102 to a second end 122
thereof, or may merely extend part-way along said member 102. In
the first case, the fluid pathway in the cylindrical member 102 may
comprise a venturi (a restriction followed by an expansion of the
pathway) which is positioned adjacent the fluid pathway of first
part 103 so that the consequential reduction in static pressure of
the inhalation air flowing from the first end 120 to the second end
122 (indicated by arrow E) encourages medicament/air to travel up
the fluid pathway of first part 103 and into the venturi before
eventually entering the lungs of the user. In the second case, the
fluid pathway in the cylindrical member 102 is closed at the first
end 120. In each case, fluid communication is provided between the
fluid pathway of first part 103 and an outlet 124 of said second
end 122.
[0077] In each spiking component 22,22' the first and second parts
103,110,112 and the sloping surfaces 104,106 may be a single
unitary component. It will be understood that the sloping surfaces
may be replaced with a non-sloping surface. However, the seal
piercing/perforating ridge will then no longer be present and the
piercing/perforating performance of the spiking component may be
adversely affected.
[0078] A further spiking component 22'' is shown in FIG. 13 of the
accompanying drawings. This alternative spiking component comprises
a similar cylindrical member 102 to that of the spiking components
22, 22' of FIGS. 11 and 12, but comprises a modified spiking
element 80'' extending perpendicularly from the exterior of the
cylindrical member 102. The spiking element 80'' may be considered
as having a first part 410 and a second part 406, 408. The spiking
element 80'' has a rectangularly shaped cross-section (the first
part 410 of the spiking element) with a free end provided with two
sloping surfaces (only one 104'' of which is shown in FIG. 13)
which extend from the major sides (as opposed to minor sides) of
the rectangular cross-section and meet one another at an apex
forming a ridge 108''. The ridge 108'' is therefore parallel to the
major sides (as opposed to minor sides) of the spiking element 80''
and, in use, the ridge 108'' pierces/perforates the seal of a
medicament compartment.
[0079] The ridge 108'' extends beyond each of the minor sides 402,
404 by virtue of two projections 406, 408 projecting from the free
end of the spiking element 80'' outwards along the major axis (of
the rectangular shaped first part) and in a cantilevered
arrangement from the exterior surface of the spiking element 80''.
The projections 406, 408 (the second part of the spiking element)
thereby provide an over-hang at the free end of the spiking element
80''. The dimension of the free end of the spiking element 80''
along the major axis is therefore greater than at the root of the
spiking element 80''.
[0080] A flow path of rectangular cross-section extends through the
spiking element 80'' and opens onto the sloping surfaces to form an
aperture 109'' therein.
[0081] In use of the modified spiking element 80'', the free end of
said element 80'' (and in particular the ridge 108'') pierces the
seal of a medicament compartment as the spiking element 80'' is
pressed into said compartment. The extension of the ridge 108''
beyond the minor sides 402, 404 of the spiking element 80''
(provided by the projections 406, 408) ensures that, as the
over-hanging projections 406, 408 are moved past the container seal
so that said seal locates nearer to the root 412 of the spiking
element 80'', the compartment seal is spaced from the minor sides
402, 404 so as to allow air to flow into said compartment between
the seal and spiking element 80''.
[0082] The width of the minor sides 402, 404 of the spiking element
80'' (i.e. the dimension of the minor sides 402, 404 in the minor
direction) is greater than that of the over-hanging projections
406, 408 and, accordingly, air flowing into a medicament
compartment between the exterior of the spiking element 80'' and
the seal may readily flow around the over-hanging projections 406,
408. This is the case even if the ridge 108'' is located in
abutment with the bottom of a medicament compartment. Air flowing
into a medicament compartment and then into the aperture 109'' is
denoted by arrow G in FIG. 13. As the air flowing into the
compartment changes direction to flow into the aperture 109'',
medicament within the compartment is entrained into the airflow and
travels towards the inhaler outlet as denoted by arrow H.
[0083] It will be understood that the over-hanging projections 406,
408 may be added to the spiking elements of the spiking components
22, 22' shown in FIGS. 11 and 12 of the accompanying drawings.
[0084] The inhaler 1 may be sealed (i.e. unopenable) so that once
the medicament within the cartridge 38 has been inhaled, the
inhaler 1 must be discarded. Alternatively, the inhaler 1 may be
provided with a lid, which allows access to the interior of the
inhaler and thereby allows for a replacement of a used cartridge
with a fresh cartridge. Accordingly, it will be understood that the
inhaler 1 may incorporate a replaceable medicament cartridge so
that, once the cartridge is exhausted, it can be replaced with a
medicament cartridge which is fully loaded with medicament.
[0085] With regard to materials of manufacture, the top cover 6,
middle cover 4, drive gear 33, counter and drive wheels 26, 30 and
base 2 may be manufactured from Acrylonitrile Butadiene Styrene and
other suitable materials already described in the specification.
Also, the arm 90, spike component 22 (and any associated roller),
and operating member 54 are manufactured from Acetyl co-polymer.
Finally, the mouthpiece 8 and associated cover 10 are manufactured
from polypropylene, and the medicament cartridge 38 is manufactured
from polystyrene (206) or cyclic olefin copolymer.
[0086] The present invention is not limited to the specific
embodiment described above. Alternative arrangements and suitable
materials will be apparent to a reader skilled in the art. For
example, in an alternative embodiment, a dose counter is not
provided. In such an inhaler, the counter wheel 26 and window 24
will not be required and may be omitted. It will be understood
therefore that the dose counter is an optional feature. It will
also be appreciated that the spiking component 22 can be made
integrally with the arm 90 so that the spiking component 22 and arm
90 form a unitary item.
[0087] In a further alternative embodiment, a modified inhaler
device is provided which is identical to the inhaler device of FIG.
1 other than in that the base and associated deformable member have
been modified. More specifically, with reference to FIGS. 9 and 9A,
it will be seen that the modified base 2' of the modified inhaler
is identical to the base 2 shown in FIG. 6 other than that the
modified base 2' is provided with two bosses 55 upstanding from the
base 2'. Each boss 55 is located adjacent a different one of the
two posts 53 upstanding from the base 2'. The position of each boss
55 relative to its associated post 53 is such that, when the
deformable member 52' is fitted on to the posts 53, each leg 57
(see FIG. 9A) abuts a different one of the two bosses 55. The
abutment of the legs 57 with the bosses 55 is such that movement of
the deformable member 52' towards the centre of the base 2' is
resisted by the bosses 55. In essence, the force with which the
resiliently deformable member 52' is sprung biased so as to be
pressed into abutment with the cartridge 38 is greater in the
modified base 2' than in the base 2 shown in FIG. 6. This is
particularly the case when the medicament cartridge 38 is rotated
within the base 2' so that the element 59 (see FIG. 9A) of the
deformable member 52' is pressed inwardly by the teeth 44 of the
cartridge 38 towards the centre of the base 2'. In this regard, it
will be understood that, as the medicament cartridge 38 is rotated
and the teeth 44 move laterally in abutment with the deformable
member 52', the deformable member 52' is pressed inwardly as the
element 59 rides over the apex of a tooth 44. In the base 2 of FIG.
6, this inward movement results in a rotation of the legs 57 about
the two upstanding posts 53. However, in the modified inhaler
device, a rotation of the legs 57 about the upstanding posts 53 is
limited by the abutment of the legs 57 with the bosses 55. There
remains a bending of the legs 57 which allows the deformable member
52' to ride over the teeth 44 as the medicament cartridge 38 is
rotated, however the restriction in the movement of the legs 57 as
a result of the bosses 55 effectively increases the biasing force
with which the element 59 is pressed against the cartridge 38 as
the cartridge 38 is rotated. A consequence of this is that, once
the deformable member 52' has ridden over the apex of a tooth 44,
the member 52' tends to more forceably locate between said tooth 44
and an adjacent tooth 44 than is the case with the arrangement of
base 2 in FIG. 6. The forceful location of the deformable member
52' between neighbouring teeth 44 has a snap-action which tends to
generate an audible click or other sound which assists in
confirming to a user that the medicament cartridge 38 has been
properly advanced.
[0088] The audible sound generated by the modified deformable
member 52' is enhanced by the provision of an element 59 which, in
the modified deformable member 52', has a thicker cross-section
than in the deformable member 52 of FIG. 6. The thicker
cross-section is provided by means of two steps 61 (see FIG. 9A).
The steps 61 allow the element 59 to have a greater thickness (and,
therefore, a greater stiffness) than the two legs 57, which are, of
course, required to bend. The greater stiffness of the element 59
further contributes to increasing the force with which the
deformable member 52' is pressed against the cartridge 38 as said
cartridge 38 rotates within the base 2'. The greater stiffness of
the element 59 also assists in generating a more audible sound as
the deformable member 52' snaps back into position between two
adjacent teeth 44.
[0089] The base 2' shown in FIG. 9 also differs from the base 2
shown in FIG. 6 in that the base 2' of FIG. 9 is provided with two
identical elements 300 extending from adjacent the upper perimeter
edge 102 of the base 2'. The elements 300 have a generally
rectangular shape with a rectangular aperture 302 provided
therethrough. The elements 300 also have a resiliently deformable
and elastic nature so that they may cooperate with protrusions (not
shown) adjacent the lower perimeter edge 106 of the middle cover 4
(see FIG. 7). The arrangement is such that, when the modified
inhaler device is assembled, the perimeter surfaces 102, 106 mate
with one another and, in so doing, the elements 300 deflect as they
pass over said protrusions on the middle cover 4 and snap-fit over
said protrusions so that each protrusion extends through a
different aperture 302 of an element 300. In this way, the base 2'
is resiliently clipped by means of the elements 300 and said
protrusions to the middle cover 4. Each protrusion may have a
rectangular shape similar to that of each aperture 302 and may also
have curved or rounded surfaces so as to cam an associated element
300 over the protrusion as the base 2' and middle cover 4 are
located in abutment with one another.
[0090] The modified base 2' may be used with any of the spiking
components 22, 22', 22'' mentioned above.
* * * * *